NCT06004362招募中不适用
Complementary and Integrative Medicine as an Online Intervention in Patients With Post-covid Syndrome - a Randomized-controlled Mixed-methods Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Short Form 36 (SF-36), Physical Functioning Scale
研究概览
简要总结
The Post-COVID syndrome is a COVID-19 sequelae disease with high individual burden. We conduct a prospective, two-arm, randomized-controlled intervention study with embedded qualitative and physiological sub-studies in a mixed-methods design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Short Form 36 (SF-36), Physical Functioning Scale
时间窗: Baseline, 10 weeks
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
次要结局
- DePaul Post-Exertional Malaise Questionnaire (DSQ-PEM)(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Chalder Fatigue Scale (CFS)(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Quality of life (EQ-5D-5L)(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Visual analog scale (VAS) physical strength(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Visual analog scale (VAS) mental strength(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Continuation of the intervention(10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- General Self-Efficacy Scale (GSE, German version: ASKU)(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Safety by recording adverse events(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Adherence to the study intervention(Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10)
- Short Form 36 (SF-36)(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Visual analog scale (VAS) headache(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Patient Health Questionnaire 9 (PHQ9)(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Post-COVID-Syndrom (PCS) Score(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Lifestyle questions (diet, alcohol, cigarettes, relaxation, hydrotherapie, nature stays, physical activity)(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Expectation regarding study intervention(Baseline)
- Perceived Stress Scale (PSS 4)(Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks)
- Satisfaction with the intervention(Week 10)
- Online diaries for assessing routine care (GP prescriptions/measures, especially medication and phytotherapy/nutritional supplements)(Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 20, week 30, week 40, week 50)
研究者
Andreas Michalsen
Principal Investigator
Charite University, Berlin, Germany
研究点 (2)
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